Thromboembolic Venous DiseaseFit-GénétiqueNCT02841085
New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE".
An observational study of Thromboembolic Venous Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Thromboembolic Venous Disease
- What is being tested?
- Genetic sample
- How many people
- 613 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2010to 14 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who: 1. / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ; 2. / were included in the "FIT" study; 3. / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
Who may be able to join
- Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:
- / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
- / were included in the "FIT" study;
- / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
- Written Consent of propositi and their members in the 2nd, 3rd and 4th respective degree to participate in this study.
Who cannot join
- Presence of detectable thrombophilia in the propositi.
- Presence of hereditary thrombophilia or detectable gained at family members.
- No information may be obtained on previous venous thromboembolism among family members on 1 degree
- Everything about the study (depending on the population and members of proband Family 1st, 2nd, 3rd and 4th degree) less than 15 years.
- The family member is an adopted child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".
Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative.
Read the detailed description
Venous thromboembolism desease is a public health problem justifying major primary and secondary prevention policy. When VTE occurs in the absence of risk factor clinically identifiable ( "idiopathic"), an inherited biological risk factor ( "inherited thrombophilia") is found in 30% of cases. However, in patients with idiopathic VTE, the risk of recurrent venous thromboembolism is very high, whether detectable inherited thrombophilia was found or not.
This first observation suggests that patients with idiopathic VTE and no detectable thrombophilia are likely to have an underlying unknown thrombophilia that are yet to be discovered.
This hypothesis is further supported by the results of the study "FIT" (Regional PHRC 2001, promoter CHU Brest, Investigator Main: Francis Couturaud, EA3878 Brest, France, and investigator Associate: Clive Kearon, McMaster University, Hamilton, Ontario, Canada), a cross international study evaluating the risk of VTE among the family members first degree of patients a first idiopathic VTE episode. In this large study cross-1950 family members first degree (topics study) of 372 patients with a first episode of VTE Idiopathic (propositi) were included (50% included in Brest and 50% inclusive in Canada). The main result is that the risk of VTE among family members first degree is high and similar, the proband either bearer or without a detectable hereditary thrombophilia. In other words, even in the absence of detectable hereditary thrombophilia, the risk of VTE among family members first degree is high. This study has identified the subjects in that it is likely they have an inherited thrombophilia which has not yet been discovered.
- Conditions
- Thromboembolic Venous Disease
- Being tested
- Genetic sample
- Keywords
- Genetic, Thrombophilia
- Medical subject headings
- Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic sampleGenetic
Blood sample or saliva collection
| Study group | Role | What they receive |
|---|---|---|
| Genetic sample | Blood sample or saliva collection to genetic research Receives: Genetic: Genetic sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research of new genetic mutations
Identify new genetic mutations predisposing risk increased Thromboembolic Venous Disease by locating and / or identifying the genes involved in subjects at high risk for thrombotic and in whom screening for detectable inherited or acquired thrombophilia was negative.
was negative.
Measured: 1 day
Secondary outcomes (1)
Quantify the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease
Quantify the importance of the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start27 May 2010
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic Venous DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841085
- Sponsor's protocol ID
- RB 09.058 Fit Génétique
- Acronym
- Fit-Génétique
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2016
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".
- ClinicalTrials.gov ID
- NCT02841085
- Acronym / sponsor ID
- Fit-Génétique / RB 09.058 Fit Génétique
- Conditions
- Thromboembolic Venous Disease
- Keywords
- Genetic, Thrombophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 May 2010 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative.
Detailed description
Venous thromboembolism desease is a public health problem justifying major primary and secondary prevention policy. When VTE occurs in the absence of risk factor clinically identifiable ( "idiopathic"), an inherited biological risk factor ( "inherited thrombophilia") is found in 30% of cases. However, in patients with idiopathic VTE, the risk of recurrent venous thromboembolism is very high, whether detectable inherited thrombophilia was found or not.
This first observation suggests that patients with idiopathic VTE and no detectable thrombophilia are likely to have an underlying unknown thrombophilia that are yet to be discovered.
This hypothesis is further supported by the results of the study "FIT" (Regional PHRC 2001, promoter CHU Brest, Investigator Main: Francis Couturaud, EA3878 Brest, France, and investigator Associate: Clive Kearon, McMaster University, Hamilton, Ontario, Canada), a cross international study evaluating the risk of VTE among the family members first degree of patients a first idiopathic VTE episode. In this large study cross-1950 family members first degree (topics study) of 372 patients with a first episode of VTE Idiopathic (propositi) were included (50% included in Brest and 50% inclusive in Canada). The main result is that the risk of VTE among family members first degree is high and similar, the proband either bearer or without a detectable hereditary thrombophilia. In other words, even in the absence of detectable hereditary thrombophilia, the risk of VTE among family members first degree is high. This study has identified the subjects in that it is likely they have an inherited thrombophilia which has not yet been discovered.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetic sample | – | Genetic: Genetic sampleBlood sample or saliva collection to genetic research |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who: 1. / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ; 2. / were included in the "FIT" study; 3. / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
Key inclusion criteria (5 listed)
- Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:
- Written Consent of propositi and their members in the 2nd, 3rd and 4th respective degree to participate in this study.
Key exclusion criteria (5 listed)
- Presence of detectable thrombophilia in the propositi.
- Presence of hereditary thrombophilia or detectable gained at family members.
- No information may be obtained on previous venous thromboembolism among family members on 1 degree
- Everything about the study (depending on the population and members of proband Family 1st, 2nd, 3rd and 4th degree) less than 15 years.
- The family member is an adopted child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic sampleBlood sample or saliva collection | Genetic | Genetic sample |
Primary outcome
Research of new genetic mutations
Time frame: 1 day
Identify new genetic mutations predisposing risk increased Thromboembolic Venous Disease by locating and / or identifying the genes involved in subjects at high risk for thrombotic and in whom screening for detectable inherited or acquired thrombophilia was negative. was negative.
1 secondary outcome
Quantify the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolic Venous Disease, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research of new genetic mutations (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.